# Zolbetuximab

Zolbetuximab (Vyloy, Astellas Pharma Europe B.V.) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: CLDN18.2 (1).

## Approved indications

### Gastric and GEJ adenocarcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Claudin (CLDN) 18.2 positive, HER2-negative | + fluoropyrimidine- and platinum-containing chemotherapy | 1st line, advanced | - |

## Products

### Vyloy

- Company: Astellas Pharma Europe B.V.
- Target: CLDN18.2-directed monoclonal antibody
- Class: Other monoclonal antibodies and antibody drug conjugates
- ATC: L01FX31
- EU approval: 19 Sep 2024
- Label revised: 11 Sep 2026
- Status: orphan medicine
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/vyloy-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/vyloy-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/vyloy

Mechanism (SmPC section 5.1): Zolbetuximab binds CLDN18.2 and depletes CLDN18.2-positive cells via antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity.

## Label wording

- **Zolbetuximab** (Vyloy), Gastric and GEJ adenocarcinoma, 1st line, advanced: “Vyloy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction (GEJ) adenocarcinoma whose tumours are Claudin (CLDN) 18.2 positive (see section 4.2).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/vyloy-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/zolbetuximab